Box 72 Protocol violations

• Patient inclusion/exclusion criteria - subjects listed as screened and nonqualifying

• Concomitant medications - the use of concomitant medications not approved in the protocol

• Adverse reactions - failure of the sponsor/investigator to report these observations on the contract report and transmit this information to the IRB and, when applicable, to the FDA

• Data entry problems - required data not entered on or missing on the contract report form; laboratory data incomplete or abnormal lab results not commented as required by the protocol

• Informing the sponsor that the study is not acceptable in a support of claims of efficacy in an application for research or marketing permit

• Sponsor inspection including termination of the IND application

• Initiation of the disqualification procedures or entry into a consent agreement with the clinical investigator

• Initiation of stock recovery by the sponsor

• Seizure of test articles if not exempted by regulation

• Injunction

The number of warning letters, NIDPOE letters and FDA action leading to investigator disqualification is illustrated in Table 7.1.

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